The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot k154 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k154 shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.The assessment is based on the information available at the time of investigation.Photographs were provided by the customer for evaluation.The complaint kit was not returned for investigation.Review of the provided photographs verify the centrifuge bowl broke as blood splatter is visible on the centrifuge chamber walls.The centrifuge bowl is no longer secured in the bowl holder.A known cause for the centrifuge bowl to dislodge from the bowl holder is when the centrifuge bowl is not properly secured in the bowl holder during installation of the kit.A material trace of the bowl assembly and its components used to build lot k154 found no related non-conformances.A device history record review did not identify any related nonconformances, deviations, or equipment maintenance events.This kit lot had passed all lot release testing.The root cause of the centrifuge bowl break was most likely due to the centrifuge bowl not being secured into the bowl holder during installation by the kit by the end user.No further action is required at this time.This investigation is now complete.(b)(4).H.M.(b)(6) 2022.
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